1. Field of the Invention
The present invention is in the field of medical foods and in the field of utilizing medical foods to reduce or minimize allergic reactions in individuals while under treatment by medical foods. More particularly, the present invention is directed to use of parboiled rice products in medical foods to reduce allergenicity of the medical food. Still more particularly the present invention is directed to a medical food composition which, when taken as a meal supplement improves the integrity of gastrointestinal mucosa and does so with minimal potential for allergic reaction.
2. Brief Description of the Prior Art
Parboiled rice is rice that has been precooked within the hull, and this food product has been known and served for a long time as an important staple of diet in many parts of the world. Chapter 8 titled "Parboiling of Rice" by K. R. Bhattacharya of the book "Rice: Chemistry and Technology", edited by Bienvenido O. Juliano and published by the American Association of Cereal Chemists Inc. St. Paul, Minn., USA, 2nd edition 1985, describes in detail the traditional as well as the modern technology for parboiling of rice and mentions the public health implications of using this product as a staple of diet in large parts of Southern Asia. For example, it was noticed primarily in Southeastern Asia during the early part of this century is that persons who consumed milled parboiled rice as the main staple of their diet tended to be free of the debilitating vitamin deficiency disease called beriberi, whereas persons whose diet mainly consisted of milled raw rice tended to suffer from this disease.
To this date and to the present inventors' best knowledge there has been no description in the prior art of the presently discovered phenomenon of this invention, namely that food products containing parboiled rice, or parboiled rice flour tend to be significantly less allergy inducing than similar products comprising other cereal, and particularly non-parboiled rice products. In this regard it is noted that whereas rice and rice products are not generally known as highly allergenic, rice-associated allergy does occur, and it occurs more frequently in those individuals who continually eat rice products or are exposed to rice pollens. For example, in Japan rice-associated allergy has become a significant problem, and rice ranks second only to eggs as the most common allergen in the Japanese diet. One aspect of the present invention is the use of parboiled rice products in medical foods to eliminate or reduce the likelihood of allergic reactions in persons who are likely to suffer an allergic reaction to rice containing or other cereal products.
Another important aspect of the background pertinent to the present invention, especially as it is presently best utilized in a medical food composition, is in the treatment of individuals suffering from certain gastrointestinal disorders. More particularly, it is well known that over 12% of adult persons in the Western World, including the United States of America, have mild to moderate gastrointestinal symptoms including altered patterns of fecal evacuation, intestinal bloating or cramping after meals, flatulence, gut pain after eating, and altered gut mucosal permeability associated with inflammatory joint disease. Many of these problems are due to altered intestinal flora, to allergic manifestations related to secretory IgA of the intestinal tract and enterometabolic toxicity reactions. All of these conditions are exacerbated by foods that have allergenic potential and by poor gut mucosal integrity/leaky gut.
Due to these abnormalities significant increases in the passive absorption of toxic substances from the bowel into the portal blood supply can occur. This in turn puts a demand on hepatic detoxification systems resulting in alteration of Phase I cytochrome P450 enzymes and Phase II conjugating enzyme systems.
Altered gut flora can also result in the production of bacterial endotoxins which in turn influence gut permeability and hepatic detoxifying enzyme systems.
The cumulative effect from direct toxicity upon the gastrointestinal mucosa from alcohol, drugs or chemicals coupled with the influence of allergy-producing dietary proteins such as gluten from wheat and casein from milk products and the release of endotoxic lipopolysaccharides or HLA-B-27 like antigens from bacteria increases gut mucosal permeability and thus increases demand upon hepatic detoxification processes. The increase in Kupffer cell activity of the liver due to these exposures can also contribute to inflammatory processes at remote sites of the body (i.e. inflammatory joint disease).
The foregoing problems constitute a series of health concerns which are being more frequently recognized to be related to altered gut permeability. The burden on the hepatic detoxification mechanism by exposure to endo and exo toxins as a consequence of a permeable gut also is known to cause the release of oxidants such as superoxide, hydroxyl radical, hydrogen peroxide and singlet oxygen. These in turn have their own deleterious effects upon the nervous, immune, endocrine, cardiovascular, and gastrointestinal systems.
Until relatively recently, that is until a few years ago, there was no nutritional product, dietary composition or medical food which has been demonstrated to favorably influence the course of these processes. Then, approximately 5 years ago a medical food composition appeared on the market under the ULTRACLEAR SUSTAIN.RTM. trade name, which is reasonably effective for the treatment of the above-noted conditions, principally for the treatment of leaky gut and related syndromes. Because the preferred embodiment of the present invention is a significantly less allergenic improvement of the above-noted medical food sold in the United States under the ULTRACLEAR SUSTAIN.RTM. trade name, the following description of certain components is pertinent as background to the present invention as well.
Fructooligosaccharides are carbohydrate compounds available from natural sources or from fermentation processes where a glucopyranose moiety is coupled with a glycosidic bond to two or more fructofuranose moieties. Inulin is a naturally occurring carbohydrate available from a variety of plant sources, where a glucopyranose moiety is coupled with a glycosidic bond to several fructofuranose moieties; the line of distinction between fructooligosaccharides and inulin is generally drawn such that when the molecule contains 4 or less fructose moieties it is classified as a fructooligosaccharide, and when it contains more than 4 fructose moieties then it is known as inulin. Nevertheless, fructooligosaccharides and inulin are considered distinct chemical entities.
It has been known in the prior art that fructooligosaccharides and inulin are largely unaffected in the stomach and small intestine of humans and numerous other mammalian species, and that these compounds provide a suitable source of nutrition to certain beneficial bacteria such as Bifidobacteria which are part of the intestinal flora of humans and other mammalian species. The following technical descriptions and scientific publications describe or are related to inulin, fructooligosaccharides and/or their effect in the mammalian digestive system and gastrointestinal flora:
P. G. Lunn, et al., Intestinal permeability, mucosal injury, and growth faltering in Gambian infants, The Lancet, Vol. 338, Oct. 12, 1991, pages 907-910; PA0 Christine A. Northrop, et al., Automated enzymatic assays for the determination of intestinal permeability probes in urine. 1. Lactulose 9 and lactose, Clinica Chimica Acta, 187, (1990), pages 79-88; PA0 Zoltan Gregus, et al., Effect of Glutathione Depletion on Sulfate Activation and Sulfate Ester Formation in Rats, Biochemical Pharmacology, Vol. 37, No. 22, pp 4307-4312, 1988; PA0 The AJS Company, Fructooligosaccharide Information Package, ZeaGen Inc., Broomfield, CO., March, 1992, pgs. 1-18; PA0 Tomotari Mitsuoka, et al., Effect of fructo-oligosaccharides on intestinal microflora, Die Nahrung, Vol. 31 (1987) 5-6, pgs. 427-436; PA0 Peter J. Perna, Fructooligosaccharides (FOS) An all Natural Food Which Promotes Bifidobacteria and Lactobacillus, ZeaGen, Inc., Broomfield, CO; PA0 J. Edelman, et al., The Mechanism of Fructosan Metabolism in Higher Plants as Exemplified in Helianthus Tuberosus, New Phytol., (1968) 67, pgs. 517-531; PA0 Marie-Anne Levrat, High Propionic Acid Fermentations and Mineral Accumulation in the Cecum of Rats Adapted to Different Levels of Inulin, American Institute of Nutrition, 1991, pgs. 1730-1737;
The present invention pertains to the use of parboiled rice or parboiled rice flour in medical foods to reduce or eliminate the allergenic potential of such foods. The below described preferred embodiment of the invention is a medical food, incorporating inulin and fructooligosaccharides as well as parboiled rice flour, which demonstrably improves gastrointestinal permeability, results in improved hepatic detoxification and reduced oxidative stress and has very low allergenic potential.